Mechanistic Effect of Walnut Consumption on Sleep Quality

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorColumbia University

About this trial

Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Equal numbers of men and women (12 male and 12 post-menopausal female)

Equal number of individuals with normal weight (18.5-24.9 kg/m2) and overweight (25-29.9 kg/m2)

Participants will self-report poor sleep quality, reflected by a global score >5 on Pittsburgh Sleep Quality Index

Disqualifiers

Diagnosed sleep disorder

smoking, excessive caffeine intake (>300 mg/day)

shift work

chronic pain

Trial design

Design model

Crossover

Treatments tested in this trial

  • Walnut consumption

    Other intervention

    Participants will add one serving (1 oz) of walnuts at their self-defined breakfast, lunch, and dinner for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day.

  • HCHS consumption

    Other intervention

    Participants will add one HCHS food (one PopTarts® pastry) to each of their 3 main meals of the day for 4 days. The study will provide study foods at 3 main meals each day to evaluate a temporal effect of the food on melatonin concentrations throughout the day. An energy-matched high-carbohydrate, high-sugar (HCHS) alternative, representative of a common US snack food, on sleep quality in adults with habitually poor sleep quality.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Walnut - washout - HCHSExperimental treatment 2 interventions
Group B: HCHS - washout - WalnutExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Serum melatonin

Serum melatonin will be measured via last testing of blood samples collected on day 4, in an inpatient setting. Repeated for each phase.

Time frame
Baseline (9AM; Hour 0), Hour 1, Hour 2, Hour 3, Hour 4, Hour 5, Hour 6, Hour 7, Hour 8, Hour 9, Hour 10, Hour 11, Hour 12, Hour 13, Hour 14, Hour 15 (Midnight)
2

Sleep quality index

Sleep quality will be assessed daily using wrist actigraphy. Variables include sleep fragmentation index and sleep efficiency. Repeated for each phase.

Time frame
Night 1, Night 2, Night 3, Night 4
3

Slow wave sleep index

Slow wave sleep will be measured using electroencephalography, in the participant's home. Repeated for each phase.

Time frame
Night 3

Secondary outcomes

1

6-sulfatoxymelatonin level

This is to measure Melatonin production in urine samples. Repeated for each phase.

Time frame
Night 4 to morning of Day 5 (Approximately up to 12 hours)
2

Body temperature

Proximal to distal body temperature gradient measured using thermochron devices (iButtons). Repeated for each phase. In patient. Over 24 hours.

Time frame
Day 4
3

Sleep quality score

Self-reported sleep quality assessed using the Karolinska Sleep Diary (higher score represents better sleep). Repeated for each phase.

Time frame
Days 2, 3, 4, 5

Other outcomes

1

NFkB level

This is to measure Endothelial cell inflammation in endothelial cells collected from a forearm vein. Repeated for each phase. Fasted sample.

Time frame
Day 4 (or Day 5)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

United States Department of Agriculture (USDA)

Collaborator

California Walnut Commission

Collaborator